Clotrimazole BP2000

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Clotrimazole BP2000 is a broad-spectrum antifungal agent belonging to the imidazole class. It appears as a white to off-white crystalline powder that is practically insoluble in water but soluble in organic solvents like ethanol and chloroform. Clotrimazole is widely used in pharmaceutical formulations for the treatment of fungal infections affecting the skin, mucous membranes, and nails. Its mechanism involves inhibition of ergosterol synthesis, a vital component of fungal cell membranes, leading to increased cell permeability and fungal cell death. BP2000 indicates compliance with British Pharmacopoeia standards ensuring high purity and consistent quality suitable for pharmaceutical applications.

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Category: Active Pharmaceutical Ingredients (APIs) Tags: Antifungal Agent, API (Active Pharmaceutical Ingredient), Clotrimazole BP, Pharmaceutical formulations, White crystalline powder

Description

Table of Contents

Clotrimazole BP2000

Primary Uses

Pharmaceuticals & Healthcare

Used extensively in topical formulations (creams, ointments, lotions) for treating superficial fungal infections such as athlete’s foot (tinea pedis), ringworm (tinea corporis), jock itch (tinea cruris), and candidiasis.
Incorporated in vaginal suppositories and creams for the treatment of vulvovaginal candidiasis.
Utilized in oral lozenges and troches for oropharyngeal candidiasis (thrush).
Active ingredient in medicated powders and sprays for fungal infections in intertriginous areas.
Sometimes formulated in nail lacquers for onychomycosis (fungal nail infections).

Secondary Uses

Veterinary Medicine

Used topically in veterinary antifungal preparations for fungal infections in animals.

Cosmetics & Personal Care

Occasionally incorporated in antifungal deodorants and foot-care products to prevent fungal growth and odor.

Research & Development

Employed in laboratory research studying antifungal mechanisms and resistance patterns.
Used in development of new antifungal delivery systems such as nanoparticles and controlled-release formulations.

KEY PRODUCT FEATURES

1. Basic Identification Attributes

Chemical Name (IUPAC): 1-[(2-Chlorophenyl)(diphenyl)methyl]-1H-imidazole
Common/Trade Name: Clotrimazole
CAS Number: 23593-75-1
HS Code: 2933.69.90
Molecular Formula: C22H17ClN2
Synonyms:
- 1-[(2-Chlorophenyl)(diphenyl)methyl]imidazole
- Canesten (brand)

2. Physical & Chemical Properties

Physical State: White to off-white crystalline powder
Color & Odor: White/off-white; odorless to faint aromatic
Melting Point: 147–150 °C
Boiling Point: Not applicable (decomposes)
Density: Approx. 1.27 g/cm³
Solubility:
- Practically insoluble in water (<0.1 mg/mL)
- Soluble in ethanol, methanol, chloroform, DMSO
Stability: Stable under normal conditions; sensitive to light and moisture over prolonged exposure

3. Safety & Hazard Attributes

Hazard Class (GHS): Not classified as hazardous but may cause skin or eye irritation
NFPA Ratings:
- Health: 1
- Flammability: 1
- Reactivity: 0
Exposure Limits: No established occupational exposure limits
Toxicity: Low systemic toxicity; possible mild skin sensitization or irritation in sensitive individuals
Reactivity: Stable; avoid strong oxidizers and acids

4. Storage & Handling Attributes

Storage Conditions: Store in tightly closed containers in a cool, dry, dark place away from direct sunlight and moisture
Container Type: Amber glass or plastic containers with airtight seals
Shelf Life: 2–3 years when stored properly
Special Handling: Use PPE (gloves, mask) to avoid dust inhalation; handle in well-ventilated areas

5. Regulatory & Compliance Attributes

BP Status: Complies with British Pharmacopoeia 2000 standards
FDA Status: Approved for pharmaceutical use as antifungal active ingredient
REACH Status: Registered
Transportation: Non-hazardous under normal transport regulations
Waste Disposal: Dispose according to pharmaceutical waste guidelines

6. Environmental & Health Impact

Ecotoxicity: Low environmental impact; not highly toxic to aquatic organisms at environmental levels
Persistence: Moderate persistence; biodegrades slowly
Bioaccumulation: Low potential
Carcinogenicity/Mutagenicity: Not classified as carcinogenic or mutagenic
Biodegradability: Slowly biodegradable

SAFETY HANDLING PRECAUTIONS

Safety Handling Precautions

PPE: Wear gloves, dust mask, and protective eyewear during handling
Handling: Avoid dust generation; handle in well-ventilated areas or under fume hoods
Storage: Keep containers tightly sealed, away from heat and light
Hygiene: Wash hands after handling; avoid ingestion, inhalation, and eye contact

First Aid Measures

Inhalation: Move to fresh air; if symptoms such as coughing or dizziness develop, seek medical attention
Skin Contact: Wash skin with soap and water; seek medical help if irritation persists
Eye Contact: Rinse immediately with plenty of water for at least 15 minutes; seek medical attention
Ingestion: Rinse mouth with water; do not induce vomiting; seek medical advice immediately

Firefighting Measures

Fire Hazards: Combustible if exposed to high temperatures or flame
Extinguishing Media: Use dry chemical, foam, or CO₂ extinguishers
Special Precautions: Firefighters should wear protective clothing and self-contained breathing apparatus
Decomposition Products: May emit toxic fumes including nitrogen oxides, hydrogen chloride, and carbon monoxide when burned